NCT07338877

RenewDisc Trial: Endoscopic Discectomy and Autologous Stem Cell Therapy for Discogenic Low Back Pain

RenewDisc Trial: A Prospective Observational Study Comparing Endoscopic Discectomy and Autologous Mesenchymal Stem Cell Therapy in Patients With Discogenic Low Back Pain

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: EPC Education s.r.o. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

he RenewDisc Trial is a prospective observational clinical study evaluating outcomes in patients with confirmed discogenic low back pain who undergo standard clinical care using endoscopic spine procedures. The study observes and compares clinical, functional, and imaging outcomes following endoscopic discectomy, endoscopic discectomy combined with autologous mesenchymal stem cell therapy, or standalone endoscopic application of autologous mesenchymal stem cells. Participants are treated according to routine clinical decision-making, and no interventions are assigned by the study protocol. Data are collected prospectively at predefined follow-up intervals to assess pain intensity, functional disability, quality of life, and structural changes on magnetic resonance imaging.

Detailed description

Discogenic low back pain is a frequent cause of chronic disability and remains challenging to treat when conservative management fails. Endoscopic spine techniques have emerged as minimally invasive options that allow targeted treatment of disc pathology with reduced tissue trauma. In parallel, regenerative approaches using autologous mesenchymal stem cells have gained interest due to their potential biological effects on disc degeneration. The RenewDisc Trial is designed as a prospective observational cohort study to systematically collect and analyze real-world clinical data from patients with confirmed discogenic low back pain who undergo endoscopic spine procedures as part of routine clinical care. The study does not assign or randomize treatments. All therapeutic decisions, including the choice of procedure, are made independently by the treating physician based on standard clinical indications and patient preference. Patients included in the study undergo one of the following standard clinical approaches: endoscopic discectomy, endoscopic discectomy combined with autologous mesenchymal stem cell application, or standalone endoscopic application of autologous mesenchymal stem cells. These approaches represent established clinical practices at participating centers. The study observes outcomes associated with each approach without altering standard care pathways. Clinical outcomes are assessed prospectively using validated patient-reported outcome measures, including pain intensity scales, functional disability, and health-related quality of life. Imaging follow-up with magnetic resonance imaging is performed at predefined intervals to evaluate structural changes of the intervertebral disc. In patients undergoing bone marrow aspiration as part of standard care, cellular characteristics of the aspirate are analyzed descriptively. Data are collected at baseline and during scheduled follow-up visits and are recorded using anonymized, randomly generated participant identifiers. The study aims to provide comparative real-world evidence on clinical, functional, and imaging outcomes associated with contemporary endoscopic and regenerative spine treatment strategies for discogenic low back pain.

Conditions

• Discogenic Low Back Pain
• Intervertebral Disc Degeneration
• Lumbar Disc Disease
• Chronic Low Back Pain

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: Slovakia